The Belgium-based ThromboGenics NV, a biotechnology company focused on vascular disease, has completed a license agreement with Bharat Biotech International Limited, Hyderabad for manufacturing, clinical development and commercialisation of THR-100, a novel variant of Recombinant Staphylokinase, in developing countries and certain industrialized countries.

THR-100 is a thrombolytic agent developed for treatment of acute myocardial infarction (AMI or heart attack) and other vascular diseases based on its ability to dissolve blood clots. In return for granting this license, ThromboGenics will earn double digit royalties on net sales. Bharat Biotech will assume responsibility for all future costs.

THR-100 has completed phase II clinical trials in Europe for treatment of AMI in over 140 patients. In the clinic, THR-100 has demonstrated efficacy equivalent to tPA, or tissue plasminogen activator (considered the "gold standard" for thrombolytic therapy), but at significantly lower patient cost than tPA. THR-100 has also shown superior efficacy to both streptokinase and urokinase, the most commonly used thrombolytic agents in the developing world for the treatment of AMI and other thrombotic conditions.

The objective of the agreement between ThromboGenics and Bharat Biotech is to develop and commercialise THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing markets.

As part of this license deal, ThromboGenics will transfer its THR-100 technology to Bharat Biotech, which will become the global manufacturer for the finished drug. With input from ThromboGenics, Bharat Biotech will be responsible for developing the commercial manufacturing process, implement a clinical development plan for phase III trials, and gain marketing authorization to commercialise THR-100, initially in India. Entry into markets outside of India is also planned as part of this alliance.

THR-100 has been shown to be one of the most fibrin-selective plasminogen activators known to date. In clinical trials conducted by ThromboGenics, various forms of recombinant staphylokinase have been administrated to over 900 patients for several thrombolytic indications, confirming its fibrin specificity.

THR-100 has also demonstrated superior efficacy to streptokinase with reduced antigenicity, or allergic reaction, a common side effect in streptokinase therapy. In addition, THR-100 offers the flexibility to be administered as a single bolus injection (for rapid administration), double bolus injection or continuous intravenous infusion, depending on the clinical indication for which it is used.

ThromboGenics has developed a robust, proprietary, and scaled-up process for production of THR-100, and owns a series of patents on its technology. The company has also created additional proprietary, patent pending, next generation variants of this drug, the rights to which are included in this license.

Commenting on the announcement, prof Désiré Collen, CEO of ThromboGenics, said: "We believe that Bharat Biotech, one of India's leading biopharmaceutical companies, will be an excellent partner for bringing THR-100 to market. This agreement is a major step forward in the
introduction of an important new thrombolytic therapy in developing regions. Drugs like tPA are too expensive for the average citizen in most parts of the developing world, and existing therapies such as streptokinase and urokinase are only effective at the cost of side effects. It is our belief that THR-100 has the potential to be a vast improvement over existing treatments for heart attack, leading to enhanced health care options in the developing world."

Dr Krishna Ella, chairman and managing director of Bharat Biotech, said: "ThromboGenics has been on the cutting edge of research and development of new products for vascular diseases. This partnership will help us bring a thrombolytic molecule to the developing world that is comparable in efficacy to tPA at affordable costs. It is an honour for Bharat Biotech to partner with ThromboGenics, and I look forward to further developing this 0partnership into a successful enterprise